ABSTRACT
Importance: The neoadjuvant treatment options for ERBB2-positive (also known as HER2-positive) breast cancer are associated with different rates of pathologic complete response (pCR). The KATHERINE trial showed that adjuvant trastuzumab emtansine (T-DM1) can reduce recurrence in patients with residual disease compared with patients treated with trastuzumab; however, T-DM1 and other ERBB2-targeted agents are costly, and understanding the costs and health consequences of various combinations of neoadjuvant followed by adjuvant treatments in the United States is needed. Objective: To examine the costs and disease outcomes associated with selection of various neoadjuvant followed by adjuvant treatment strategies for patients with ERBB2-positive breast cancer. Design, Setting, and Participants: In this economic evaluation, a decision-analytic model was developed to evaluate various neoadjuvant followed by adjuvant treatment strategies for women with ERBB2-positive breast cancer from a health care payer perspective in the United States. The model was informed by the KATHERINE trial, other clinical trials with different regimens from the KATHERINE trial, the Flatiron Health Database, McKesson Corporation data, and other evidence in the published literature. Starting trial median age for KATHERINE patients was 49 years (range, 24-79 years in T-DM1 arm and 23-80 years in trastuzumab arm). The model simulated patients receiving 5 different neoadjuvant followed by adjuvant treatment strategies. Data analyses were performed from March 2019 to August 2020. Exposure: There were 4 neoadjuvant regimens: (1) HP: trastuzumab (H) plus pertuzumab (P), (2) THP: paclitaxel (T) plus H plus P, (3) DDAC-THP: dose-dense anthracycline/cyclophosphamide (DDAC) plus THP, (4) TCHP: docetaxel (T) plus carboplatin (C) plus HP. All patients with pCR, regardless of neoadjuvant regimen, received adjuvant H. Patients with residual disease received different adjuvant therapies depending on the neoadjuvant regimen according to the 5 following strategies: (1) neoadjuvant DDAC-THP followed by adjuvant H, (2) neoadjuvant DDAC-THP followed by adjuvant T-DM1, (3) neoadjuvant THP followed by adjuvant DDAC plus T-DM1, (4) neoadjuvant HP followed by adjuvant DDAC/THP plus T-DM1, or (5) neoadjuvant TCHP followed by adjuvant T-DM1. Main Outcomes and Measures: Lifetime costs in 2020 US dollars and quality-adjusted life-years (QALYs) were estimated for each treatment strategy, and incremental cost-effectiveness ratios were estimated. A strategy was classified as dominated if it was associated with fewer QALYs at higher costs than the alternative. Results: In the base-case analysis, costs ranged from $415â¯833 (strategy 3) to $518â¯859 (strategy 4), and QALYs ranged from 9.67 (strategy 1) to 10.73 (strategy 3). Strategy 3 was associated with the highest health benefits (10.73 QALYs) and lowest costs ($415â¯833) and dominated all other strategies. Probabilistic analysis confirmed that this strategy had the highest probability of cost-effectiveness (>70% at willingness-to-pay thresholds of $0-200,000/QALY) and was associated with the highest net benefit. Conclusions and Relevance: These results suggest that neoadjuvant THP followed by adjuvant H for patients with pCR or followed by adjuvant DDAC plus T-DM1 for patients with residual disease was associated with the highest health benefits and lowest costs for women with ERBB2-positive breast cancer compared with other treatment strategies considered.
Subject(s)
Breast Neoplasms/genetics , Breast Neoplasms/therapy , Neoadjuvant Therapy/economics , Receptor, ErbB-2/genetics , Ado-Trastuzumab Emtansine/economics , Ado-Trastuzumab Emtansine/therapeutic use , Adult , Aged , Anthracyclines/economics , Anthracyclines/therapeutic use , Antibodies, Monoclonal, Humanized/economics , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents, Immunological/economics , Antineoplastic Agents, Immunological/therapeutic use , Antineoplastic Agents, Phytogenic/economics , Antineoplastic Agents, Phytogenic/therapeutic use , Breast Neoplasms/pathology , Case-Control Studies , Cost-Benefit Analysis , Cross-Linking Reagents/economics , Cross-Linking Reagents/therapeutic use , Drug Therapy, Combination , Female , Humans , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Middle Aged , Paclitaxel/economics , Paclitaxel/therapeutic use , Quality-Adjusted Life Years , Trastuzumab/economics , Trastuzumab/therapeutic use , Tubulin Modulators/economics , Tubulin Modulators/therapeutic use , United States/epidemiologyABSTRACT
Aims: Post-operative atrial fibrillation (POAF) occurs in 20-50% of patients amid post-operative stay after Cardiac Surgery. We intend to determine whether colchicine therapy in patients undergoing cardiac surgery is a cost-effective strategy for prevention of POAF. To undertake cost utility analysis and calculate incremental cost utility ratio (ICUR) for colchicine therapy in these subgroup of patients. Methods and results Design: Decision tree model to calculate the ICUR comparing two treatment strategies in patients undergoing cardiac surgery. One wherein patients received colchicine along with usual care and second where they received placebo or just usual care. Cost utility analysis was undertaken using relevant data from the systematic review and meta-analysis of the available randomized controlled trials till June 2016 and mean cost calculations from validated available sources across various jurisdictions. Results: Colchicine treatment based on mean costs for life expectancy calculated at 10 years' post-surgery using recommended discounting rates of 3.5% was 17544.80 cheaper per quality-adjusted life-year (QALY) gained. The incremental cost is negative and the incremental effect (QALY) is positive (South East quadrant), Hence the intervention of colchicine treatment is unequivocally cost-effective, meaning it is dominant and achieves better outcomes at a lower cost. Conclusion: Our findings provide a benchmark for current and future analyses relating to effectiveness of colchicine on POAF events after cardiac surgery. Currently, there are few reports that provide cutting edge estimates of the higher expenses associated with POAF. Future analyses should likewise explore the impact of added costs from using pharmacologic efforts to prevent and treat POAF after cardiac surgery.
Subject(s)
Atrial Fibrillation , Cardiac Surgical Procedures/adverse effects , Colchicine/economics , Postoperative Complications , Atrial Fibrillation/economics , Atrial Fibrillation/etiology , Atrial Fibrillation/prevention & control , Colchicine/therapeutic use , Cost-Benefit Analysis , Humans , Tubulin Modulators/economics , Tubulin Modulators/therapeutic useABSTRACT
OBJECTIVES: The clinical efficacy and safety of drug-coated balloon (DCB) angioplasty in patients with coronary in-stent restenosis (ISR) has been demonstrated. The objective of this article is to provide comparative cost efficacy data for DCB angioplasty in various countries based on the original methodology of the Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) in 2010. STUDY DESIGN: Published and unpublished Health Technology Assessment (HTA) reports were evaluated for comparison in selected countries. Furthermore, a systematic review of economic evaluations of DCB angioplasty versus standard treatments (uncoated balloon angioplasty or drug-eluting stent implantations) was conducted. METHODS: National cost efficacy data were evaluated using Markov state transition models which were adapted to fit each country's device and procedure related costs. The clinical input for adverse events was defined with two relevant trials for in-stent restenosis of bare metal stents (BMS-ISR) and of drug-eluting stents (DES-ISR). RESULTS: In the UK, Germany, Switzerland, South Africa, Japan and Brazil, DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR. CONCLUSIONS: DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers' point of view.
Subject(s)
Angioplasty, Balloon, Coronary/economics , Coated Materials, Biocompatible/economics , Coronary Restenosis/economics , Coronary Restenosis/therapy , Paclitaxel/economics , Practice Guidelines as Topic , Tubulin Modulators/economics , Angioplasty, Balloon, Coronary/instrumentation , Cost Savings , Cost-Benefit Analysis , Global Health , HumansABSTRACT
The aim of the study was to determine the economical impact of juvenile idiopathic arthritis (JIA) and familial Mediterranean fever (FMF) in Turkey. A total of 100 patients (69 F/31 M) with JIA and 100 with FMF (68 F/32 F) who were consecutively seen in the outpatient clinic of the pediatric rheumatology department at Cerrahpasa Medical School between August 2008 and January 2009 were studied. Cost data were collected through a questionnaire filled out by the parents. The mean age (JIA: 11 ± 5 years; FMF:12 ± 4 years) and mean disease duration (JIA:5 ± 3 years; FMF: 4 ± 3 years) of the patients were similar. JIA patients were assigned to 5 subtypes (polyarticular: n = 45, oligoarticular: n = 30, systemic onset: n = 13, psoriatic: n = 6, and enthesopathy-related JIA: n = 6). Forty-nine percent of the patients with JIA were treated with anti-TNF drugs and 61% with DMARDs. All patients with FMF were using colchicine. The total annual cost of JIA (
Subject(s)
Arthritis, Juvenile/economics , Familial Mediterranean Fever/economics , Adolescent , Antirheumatic Agents/economics , Antirheumatic Agents/therapeutic use , Arthritis, Juvenile/drug therapy , Child , Colchicine/economics , Colchicine/therapeutic use , Drug Therapy, Combination/economics , Familial Mediterranean Fever/drug therapy , Female , Health Expenditures , Humans , Male , Tubulin Modulators/economics , Tubulin Modulators/therapeutic use , Tumor Necrosis Factor-alpha/antagonists & inhibitors , TurkeyABSTRACT
Eribulin mesylate (Halaven-Eisai) has been approved by the FDA for treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapy regimens for metastatic cancer. Prior therapy should have included an anthracycline and a taxane in either an adjuvant or metastatic setting. Other drugs used to treat anthracycline- and taxane-refractory metastatic breast cancer include capecitabine (Xeloda), gemcitabine (Gemzar, and others) and vinorelbine (Navelbine, and others).